SERVICES

• About U.S. Validation Services, LLC

  

  With more than 30 years of industry experience, we excel in delivering pragmatic and budget-friendly solutions that guarantee the validation of your facilities, utility systems, computerized systems, software, and equipment, all while enhancing FDA compliance.
  Our seasoned team, with expertise in GMP-regulated industries, will guide you through the validation process for your facilities, utility systems, and equipment

• Validation Planing And Management

  • Validation Program Auditing and Optimization
  • Policy and Procedure Development
  • Validation Master Plan Preparation
  • Project Management
  • Protocol Preparation (IQ,OQ, PQ)
  • Deviation Resolution - Corrective and Preventive Action (CAPA)

• Equipment, Facility, and Utility Systems Validation

  • Compliance Assessments
  • Validation Master Plan Development
  • Validation Project Management
  • Development of Quality System documentation (Plans, SOPs, Protocols, Schedules, Reports etc)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • GAP Analysis and Remediation
  • Risk Analysis

• Computerized Systems Validation

  • Software Vendor Audits
  • Validation Master Planning
  • User Requirements Specifications (Business Requirements)
  • Validation Protocols
  • Functional Specifications

• CFR 21, Part 11 Electronic Records and Electronic Signatures

  • Assessment
  • Remediation Plan

• Calibration Program Management

  • Metrology Program Auditing and Optimization
  • Metrology Policy Review and Preparation
  • Calibration/Re-calibration Procedures Review and Preparation